Advanced Practice Nurse, Clinical Trials

Clinical Research Nurse C

Clinical Research Nursing is the specialized practice of professional nursing focused on maintaining equilibrium between care of the research participant and fidelity to the research protocol. care coordination and continuity; contribution to clinical science; and study management throughout a variety of professional roles, practice settings, and clinical specialties. Principle duties include coordination and implementation of Phase I- IV clinical trials, coordination and continuity of care for patients enrolled in clinical trials, collaboration among multiple stakeholders involved in the implementation of clinical trials for which they are assigned, and adherence to all applicable guidelines, policies, and procedures related to clinical care and its intersection with the clinical research protocol. Elicit the research participant's values preferences, expressed needs, knowledge of the healthcare situation, understanding of research protocol requirements, and acceptance of risks versus benefits. Apply ethical, legal, and privacy guidelines and policies to the collection, maintenance, use, and dissemination of data and information. Care Coordination and Continuity

Collaborate with interdisciplinary team to create a plan of care that allows for safe and effective collection of clinical research data. Provide nursing leadership within the interdisciplinary team. Coordinate referrals to appropriate interdisciplinary services outside the immediate research team. Provide nursing expertise to community based health care personnel related to study participation.

Ability to review protocol for potential enrollment/ retention issues that may occur regarding logistics of the care delivery system and make recommendations to reduce disruption to protocol compliance and safe patient care. Coordinate development of research protocols and treatment plans with physicians, pharmacists, other nurses, research coordinators, and pharmaceutical companies. Disseminate clinical expertise and best practices related to clinical research through presentations, publications, and/or interactions with nursing colleagues. Serve as an expert in specialty area (ex. Grant reviewer, editorial board, presenter). Participate in query and analysis of research data. Collaborate with interdisciplinary team to develop innovations in care delivery that have potential to improve patient outcomes and data collection. Identify questions appropriate for clinical nursing research as a result of study team participation (ex. Viral shedding studies for gene therapy and implications for nurses administering IP). Perform secondary data analysis to contribute to the development of new ideas. Serve as a resource to the new investigator.

Collects comprehensive data pertinent to the research protocol requirements and the research participant's health and/ or situation. Staff nurses caring for research patients may not be familiar with the research process- must work alongside the assigned bedside nurse to provide necessary information about the research study including intervention and potential adverse events. Conduct study interventions in accordance with PSOM and health system policies. Provide oversight and coordination of radiographic imaging and laboratory findings. Conduct assessments, collect medical history, and adverse event assessment. Monitor patient care, assess patient status, and monitor treatment side effects. Obtain specimens (including venipuncture) Provide patient and family education and support. Demonstrate understanding of standard of care activities related to the care of the research participants and requirements of the protocol in which they are enrolled. Demonstrate knowledge of pathophysiology, pharmacology, and toxicology as related to medicines discovery and development. Coordinate patient visits and any necessary testing. Conduct initiation, monitoring, and close-out visits with sponsors and/or CROs. Confirm patient eligibility and registration. Complete case report forms (CRFs), and resolve data queries with sponsors and CROs. Process and ship biologic specimens (blood, urine, stool, nasal swabs, serum, etc) as directed by the clinical trial protocol. Obtain diagnostic materials such as slides from pathology and/or scans from radiology and ship to sponsor/independent review per protocol guidelines. Attend investigator and site initiation meetings. Participate in the conduct of audits by study sponsors, CROs, the FDA, NCI, and Penn Regulatory bodies (OCR, Cancer Center DOCM), and other groups. Prepare and process all regulatory documentation through the Institutional Review Board (IRB) and other entities as required, including amendments, continuing reviews, and adverse event reporting. Prepare and process all regulatory documentation with pharmaceutical companies and clinical research organizations (CROs). Resolve regulatory related queries with IRB, study sponsors, and CRO. Conduct initiation, monitoring and closeout visits with sponsors and/or CROs.

Searches, retrieves, and manages data needed to make decisions, using information and knowledge management systems. Ability to create clear treatment plans for administration of investigational interventions in collaboration with the pharmacy and IT teams that can be utilized in the Electronic Medical Record by clinical and research personnel. Assists others in retrieving and managing data needed to make decisions, using information and knowledge management systems.

Effectively collaborates and applies innovative, systems thinking to engage in systematic, evidence-based problem solving and decision making to promote effective changes within a complex care delivery system. Analyzes and interprets the barriers to effective communication within the health care setting and develops strategies to improve outcomes. Effectively engages in the process of cooperation, coordination, and collaboration in an effort to provide for safe, quality outcomes for patients within inter and intra-professional teams, including virtual teams.

Registered Nurse with Licensure in Commonwealth of Pennsylvania without restriction or limitation and 2-3 years of experience required. Two to three years' clinical research experience preferred• Basic Life Support Certification (CPR) required and maintained every 2 years• ACLS preferred and may be required in specific environments (ICU settings, ED, etc)• Applicable Professional Certification preferred (ex. CCRP, CRN-BC, OCN)• Effective problem-solving abilities• Effective communication and writing skills• Ability to multi-task• Demonstrated ability to work as part of a team as well as independently• Knowledge of IRB and human research protection regulations required

Perelman School of Medicine

Salary offers are made based on the candidate's qualifications, experience, skills, and education as they directly relate to the requirements of the position, and in alignment with salary ranges based on external market data for the job's level. Internal organization and peer data at Penn are also considered.

Candidates are considered for employment without regard to race, color, sex, sexual orientation, religion, creed, national origin (including shared ancestry or ethnic characteristics), citizenship status, age, disability, veteran status or any class protected under applicable federal, state or local law.

Health, Life, and Flexible Spending Accounts : Penn offers comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits to protect you and your family's health and welfare. You can also use flexible spending accounts to pay for eligible health care and dependent care expenses with pre-tax dollars.

You, your spouse, and your dependent children can get tuition assistance here at Penn. Your dependent children are also eligible for tuition